Dynamic stimulation adjustment for identification of a neural fulcrum

• US 9,950,169 B2
• Filed: 04/25/2014
• Issued: 04/24/2018
• Est. Priority Date: 04/25/2014
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc), East Tennessee State University (University and Community College System Tennessee State)
• Original Assignee: Cyberonics, Inc, East Tennessee State University (University and Community College System Tennessee State)
• Inventors: Libbus, Imad, Amurthur, Badri, KenKnight, Bruce H., Ardell, Jeffrey L.
• Primary Examiner(s): Patton, Amanda
• Application Number:
  US14/262,270
• Publication Number:
  US 20150306394A1
• Time in Patent Office: 1,460 Days
• Field of Search: 607 2, 607 6, 607 9, 607 59, 607 62
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Systems and methods are provided for delivering neurostimulation therapies to patients for treating chronic heart failure. A computer-implemented control system is operated to automatically identify a neural fulcrum zone based on a monitored patient physiological response. Ongoing neurostimulation therapy is delivered within the neural fulcrum zone.

Claims

1. A neurostimulation system, comprising:

an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said neurostimulator adapted to deliver a stimulation signal to a patient, said stimulation signal comprising an ON time and an OFF time; and

a control system programmed to;

monitor a heart rate of a patient implanted with the IMD during delivery to the patient of a plurality of stimulation signals at a first frequency, each stimulation signal having at least one parameter setting different than the parameter settings of the other stimulation signals in the plurality of stimulation signals, wherein said monitoring the heart rate comprises monitoring a baseline heart rate during the OFF time periods of the stimulation signal and monitoring a heart rate response during the ON time periods of the stimulation signal;

identify a first subset of the plurality of stimulation signals during which tachycardia is detected during the ON time periods of the stimulation signal;

identify a second subset of the plurality of stimulation signals during which bradycardia is detected during the ON time periods of the stimulation signal; and

identify a neural fulcrum zone corresponding to a third subset of the plurality of stimulation signals during which a transition heart rate response is detected during the ON time periods of the stimulation signal, said transition heart rate response between tachycardia and bradycardia and comprising a heart rate change from the baseline heart rate of less than 5%.

2. A system according to claim 1, wherein:

the IMD further comprises a heart rate sensor; and

the control system is provided in the IMD.

3. A system according to claim 1, wherein:

the control system is in wireless communication with the IMD.

4. A system according to claim 1, wherein:

the control system is programmed to monitor the baseline heart rate during the OFF time periods of the stimulation signal after a delay period following the ON time periods of the stimulation signal.

5. A system according to claim 1, wherein:

the control system is programmed to calculate a baseline heart rate average of a plurality of OFF time periods of the stimulation signal, and to calculate a heart rate response average of a plurality of ON time periods of the stimulation signal.

6. A system according to claim 1, wherein the control system is further programmed to:

activate the IMD to chronically deliver stimulation signals in the identified neural fulcrum zone.

7. A system according to claim 6, wherein the control system is programmed to activate the IMD to chronically deliver stimulation signals in the identified neural fulcrum zone by activating the IMD to treat chronic cardiac dysfunction.

8. A system according to claim 1, wherein:

said at least one parameter setting different than the parameter settings of the other stimulation signals in the plurality of stimulation signals comprises amplitude.

9. A system according to claim 1, wherein:

said at least one parameter setting different than the parameter settings of the other stimulation signals in the plurality of stimulation signals comprises pulse width.

10. A system according to claim 1, wherein:

said at least one parameter setting different than the parameter settings of the other stimulation signals in the plurality of stimulation signals comprises duty cycle.

11. A system according to claim 1, wherein:

said at least one parameter setting different than the parameter settings of the other stimulation signals in the plurality of stimulation signals comprises frequency.

12. A system according to claim 1, wherein the control system is further programmed to:

activate the IMD to deliver to the patient the plurality of stimulation signals, each stimulation signal comprising a greater amplitude than the immediately previous stimulation signal.

13. A system according to claim 1, wherein the control system is further programmed to:

activate the IMD to deliver to the patient a second plurality of stimulation signals at a second frequency different than the first frequency, each stimulation signal in the second plurality of stimulation signals having at least one parameter setting different than the parameter settings of the other stimulation signals in the second plurality of stimulation signals;

monitor a heart rate of the patient during said delivery of the second plurality of stimulation signals, wherein the tachycardia is detected during a first subset of the second plurality of stimulation signals and the bradycardia is detected during a second subset of the second plurality of stimulation signals; and

identify a second neural fulcrum zone corresponding to a third subset of the second plurality of stimulation signals during which the transition heart rate response is detected.

14. A system according to claim 13, wherein the control system is further programmed to:

activate the IMD to chronically deliver stimulation signals in the identified second neural fulcrum zone.

15. A system according to claim 13, wherein the control system is configured to activate the IMD to chronically deliver stimulation signals in the identified second neural fulcrum zone by activating the IMD to treat chronic cardiac dysfunction.

16. A system according to claim 1, wherein the control system is further programmed to:

prior to activating the IMD to deliver to the patient the plurality of stimulation signals at the first frequency, complete a titration process in which stimulation intensity is gradually increased over a period of time as the patient adapts to the stimulation.

17. A system according to claim 1, wherein:

said IMD is adapted to deliver the stimulation signal to a vagus nerve of the patient.

18. A method of operating an implantable medical device (IMD) comprising a neurostimulator coupled to an electrode assembly, said neurostimulator adapted to deliver a stimulation signal comprising an ON time and an OFF time, said method comprising:

operating a control system to activate the IMD to deliver to the patient a plurality of stimulation signals at a first frequency, each stimulation signal having at least one parameter setting different than the parameter settings of the other stimulation signals in the plurality of stimulation signals;

monitoring a baseline heart rate during the OFF time periods of the stimulation signal;

monitoring a heart rate response during the ON time periods of the stimulation signal;

detecting with said control system tachycardia during a first subset of the plurality of stimulation signals and bradycardia during a second subset of the plurality of stimulation signals; and

operating the control system to identify a neural fulcrum zone corresponding to a third subset of the plurality of stimulation signals during which the control system detects a transition heart rate response, said transition heart rate response being between tachycardia and bradycardia and comprising a heart rate change from the baseline heart rate of less than 5%.

19. A method according to claim 18, wherein:

said operating the control system comprises operating an implanted control system.

20. A method according to claim 18, further comprising:

automatically activating the IMD to chronically deliver stimulation signals in the identified neural fulcrum zone.

21. A method according to claim 20, wherein said automatically activating the IMD to chronically deliver stimulation signals in the identified neural fulcrum zone comprises activating the IMD to treat chronic cardiac dysfunction.